The Roche Diagnostics Magnesium reagent is intended for use for the quantitative determination of magnesium in human serum, plasma, and urine on automated clinical chemistry analyzers.

Device Description

Magnesium, in the presence of EGTA, is coupled with xylidyl blue in an alkaline solution. Magnesium + xylidyl blue alkaline -> purple complex. EGTA in the reagent complexes with calcium, so that only magnesium reacts with the indicator. The intensity of the color of the purple complex formed is proportional to the magnesium concentration and can be measured photometrically.

AI/ML Overview

The provided text is a 510(k) summary for a medical device, the Roche Diagnostics Magnesium Reagent. It is a premarket submission to the FDA for a Class I in vitro diagnostic device, and as such, the focus is on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results with acceptance criteria in the same way one would for a novel medical imaging AI device.

Therefore, much of the requested information (like effect size of human readers with/without AI, expert ground truth adjudication, sample size for training sets, etc.) is not applicable to this type of submission for this specific device.

However, I can extract and interpret the information that is present in the context of device performance and substantial equivalence:

Device: Roche Diagnostics Magnesium Reagent

1. Table of Acceptance Criteria and Reported Device Performance

For an in vitro diagnostic reagent like this, "acceptance criteria" are typically defined by demonstrating that the new device performs comparably to a legally marketed predicate device, especially in terms of accuracy, precision, linearity, and interference. The document primarily focuses on similarities and asserting substantial equivalence based on these.

Characteristic	Acceptance Criteria (Implied by Predicate Comparison)	Reported Device Performance (Roche Diagnostics Magnesium Reagent)
Intended Use	Measurement of magnesium in human serum, plasma, and urine	Measurement of magnesium in human serum, plasma, and urine (identical)
Sample Type	Serum, plasma, CSF; Urine, acidified to pH 1	Serum, plasma, CSF; Urine, diluted with 0.9% saline or water (difference noted, but implied to be equivalent for clinical utility)
Use on Automated Chemistry Analyzers?	Yes	Yes (identical)
Test Principle	Magnesium reacted with calmagite (predicate)	Magnesium reacted with xylidyl blue (difference noted, but implied to produce equivalent results)
Calibration	Two points, blank (saline) and ~1.4 mmol/L magnesium	Two points, blank (saline) and ~1.4 mmol/L magnesium (identical)
Calibration Stability	Perform new calibration every 24 hours, and with bottle/reagent lot change	Perform new calibration with bottle or reagent lot change (improved stability: less frequent calibration required)
Kit Configuration, Reagent Preparation	R1, R2 liquid, ready-to-use	R1, R2 liquid, ready-to-use (identical)
Reagent On-board Stability	1 week	3 weeks (improved stability)
Overall Performance	Substantially equivalent to predicate	Substantially equivalent to predicate as demonstrated by specific data in Section V (not provided in this excerpt but referenced).

Note: The document explicitly states: "Specific data on the performance of the system have been incorporated into the draft labeling in Section V of this submission." This section itself is not provided, but it would contain the detailed studies (e.g., accuracy against a reference method, precision, linearity, interference studies) that formally define performance parameters and criteria comparisons to the predicate. The summary focuses on features of the device rather than numerical performance data in the provided text.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the excerpt. For an in vitro diagnostic device validation study, a "test set" would typically refer to patient samples used to evaluate accuracy, precision, and other analytical performance characteristics. The document mentions "specific data on the performance of the system" in Section V, which would likely include details on the test samples used, their number, and possibly their origin.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable and therefore not provided for this type of in vitro diagnostic device (reagent for quantitative determination). "Ground truth" for a chemical measurement in clinical chemistry is typically established by reference methods or highly accurate analytical instruments, not by expert interpretation.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided for this type of in vitro diagnostic device. Adjudication methods like "2+1" are relevant for subjective interpretations (e.g., medical image assessment), not for quantitative chemical measurements.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

This information is not applicable and therefore not provided. This device is a diagnostic reagent, not an AI-assisted diagnostic tool.

6. If a Standalone (i.e., algorithm-only without human-in-the-loop performance) Was Done

This information is not applicable and therefore not provided. This device is a chemical reagent, not an algorithm.

7. The Type of Ground Truth Used

For the performance assessment of this in vitro diagnostic reagent, the "ground truth" would implicitly be established through:

Reference materials/known concentrations: For accuracy and linearity studies, the device's measurements would be compared against samples with known, precise magnesium concentrations.
Comparison to a legally marketed predicate device: The core of a 510(k) submission is to demonstrate that the new device performs equivalently to an existing, cleared device. Therefore, the predicate device's results often serve as a de facto "ground truth" or benchmark for demonstrating substantial equivalence on patient samples.
Internal validation against established analytical methods: The performance data in Section V would likely include comparisons to established analytical methods for magnesium quantification to ensure accuracy and precision.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. This device is a chemical reagent, not a machine learning algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable and therefore not provided. As above, no training set is relevant for this device.

Summary

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510(k) Summary

Introduction	According to the requirements of 21 CFR 807.92, the following informationprovides sufficient detail to understand the basis for a determination ofsubstantial equivalence.
1) Submittername, address,contact	Boehringer Mannheim Corporation, dba Roche Diagnostics9115 Hague Rd.Indianapolis, IN 46250(317) 845-2000Contact Person: Luann OchsDate Prepared: September 18, 1998
2) Device name	Proprietary name: Roche Diagnostics Magnesium ReagentCommon name: magnesium test systemClassification name: photometric method, magnesium 75JGJDevice Class I
3) Predicatedevice	We claim substantial equivalence to the currently marketed RocheDiagnostics Magnesium reagent system, catalog number 804551,manufactured by Bio-Analytical labs. K810084.
4) DeviceDescription	Magnesium, in the presence of EGTA, is coupled with xylidyl blue in analkaline solution.Magnesium + xylidyl blue alkaline -> purple complexEGTA in the reagent complexes with calcium, so that only magnesium reactswith the indicator. The intensity of the color of the purple complex formed isproportional to the magnesium concentration and can be measuredphotometrically.

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510(k) Summary, Continued

5) Intended use	The Roche Diagnostics Magnesium reagent is intended for use for the quantitative determination of magnesium in human serum, plasma, and urine on automated clinical chemistry analyzers.
6) Comparison to predicate device	The Roche Diagnostics Magnesium reagent is substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed Roche Diagnostics Magnesium reagent system, catalog number 804551, manufactured by Bio-Analytical Labs, K810084.

The following table illustrates the similarities between the Roche Diagnostics Magnesium Reagent and the predicate device. Specific data on the

Magnesium Reagent and the predicate device. Specific data on the performance of the system have been incorporated into the draft labeling in Section V of this submission. Labeling for the predicate device is provided in Section VI.

Feature	New MagnesiumReagent	Predicate MagnesiumReagent
Intended Use	Measurement ofmagnesium	Measurement ofmagnesium
Sample Type	Serum, plasma, CSF,no preparation required.Urine, diluted with0.9% saline or water	Serum, plasma, CSF,no preparation required.Urine, acidified to pH 1prior to assay
Use on AutomatedChemistry Analyzers?	Yes	Yes
Test Principle	Magnesium is reactedwith xylidyl blue in analkaline solution, in thepresence of EGTA,resulting color ismeasured spectro-photometrically	Magnesium is reactedwith calmagite in analkaline solution, in thepresence of EGTA andKCN, resulting color ismeasured spectro-photometrically
Calibration	Two points, blank(saline) and about 1.4mmol/L (2.8mEq/L)magnesium	Two points, blank(saline) and about about1.4 mmol/L (2.8mEq/L)magnesium

Similarities:

Continued on next page

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510(k) Summary, Continued

Comparison to predicate device (continued)

Feature	New MagnesiumReagent	Predicate MagnesiumReagent
Calibration Stability	Perform a newcalibration with a bottleor reagent lot change	Perform a newcalibration every 24hours, and with a bottleor reagent lot change
Kit Configuration,Reagent Preparation	R1, liquid, ready-to-useR2, liquid, ready-to-use	R1, liquid, ready-to-useR2, liquid, ready-to-use
Reagent On-boardStability	3 weeks	1 week

Similarities:

6) Comparison Differences: to predicate

device,

continued

There are no significant differences between the Roche Diagnostics Magnesium reagent and the predicate device for purposes of considering substantial equivalence.

Performance characteristics:

The performance of the Roche Diagnostics Magnesium reagent is substantially equivalent to other products in commercial distribution intended for similar use. Most notabiy it is substantially equivalent to the currently marketed Roche Diagnostics Magnesium reagent system, catalog number 804551, manufactured by Bio-Analytical Labs, K810084.

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Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the seal is a stylized image of an eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 21 1998

Luann Ochs . Requlatory Program Manager Boehringer Mannheim Corporation, dba Roche Diagnostics 9115 Haque Road P.O. Box 50457 46250-0457 Indianapolis, Indiana

Re: K983416 Roche Diagnostics Magnesium Reagent Requlatory Class: I Product Code: JGJ Dated: September 18, 1998 Received: September 29, 1998

Dear Ms. Ochs:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਬ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Gutman.

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure ..

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K983416 510(k) Number (if known): Device Name: Roche Diagnostics Magnesium Reagent

Indications for Use:

The Roche Diagnostics Magnesium reagent is intended for use for the quantitative determination of magnesium in human serum, plasma, and urine on automated clinical chemistry analyzers.

According to the Code of Federal Regulations, Title 21 (Food and Drugs), Part 862.1495, a Magnesium test system is a device intended to measure magnesium levels in serum and plasma. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium). It is classified in Class I.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K 983916

Regulation Number and Section

§ 862.1495 Magnesium test system.

(a)
Identification. A magnesium test system is a device intended to measure magnesium levels in serum and plasma. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium).(b)
Classification. Class I.